An Actual Use, Open-label Study Assessing Usability of Remote Assist to Program Cochlear Implant Recipients

Launched by COCHLEAR · Aug 2, 2021

Keywords

ClinConnect Summary

Clinical management of cochlear implant (CI) recipients involve programming, counselling, performance evaluation and habilitation. The standard practice for this management involves frequent clinical visits in the first year after implantation and annual visits for the rest of the recipient's life. The need to travel to the clinic for follow up appointments can pose significant challenges for recipients, particularly those who live far away from the clinic. There have been reports of recipients being lost to follow up due to the difficulties in travelling to the clinic. The inconvenience of...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adults (≥18 years).
• • 2. Implanted with the below cochlear implants in one or both ears. CI500 series (CI512, CI513, CI522, CI532,), CI600 series (CI612, CI622, CI632), Freedom series (CI24RE (ST), CI24RE (CA), CI24RE (CS), CI422).
• • 3. At least 3 months experience with the cochlear implant.
• • 4. Willing and able to provide written informed consent.
• Exclusion Criteria:
• • 1. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
• • 2. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
• • 3. Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.
• • 4. Currently participating or participated in another interventional clinical study/trial in the past 30 days, or if less than 30 days the prior investigation was Cochlear sponsored and determined by the investigator to not impact clinical findings of this investigation.